Catalog Number

OL351350

Brand Name

Onatec

Version/Model Number

OL351350

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

dcd13113-b919-4708-9105-cc049fba1356

Public Version Date

May 03, 2022

Public Version Number

1

DI Record Publish Date

April 25, 2022

Package DI Number

10848782032966

Quantity per Package

12

Contains DI Package

00848782032969

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box